Regenerative Processing Plant, LLC
FDA inspection history across 2 sites, 2023 to 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2023: one Form 483; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One Form 483 and one warning letter, at Palm, Florida and Palm Harbor, Florida.
Cited most
Across all Regenerative Processing Plant observations on file
- 21 CFR 211.42(a)Design and construction features2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(b)(1)General requirements1
- 21 CFR 211.166(a)Stability testing1
The complete Regenerative Processing Plant file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Palm Harbor, Florida
One warning letter · 2024
Latest: Warning letter, Aug 16, 2024 →Palm, Florida
One Form 483 · 2023 · 15 observations
Latest: Form 483, Jun 30, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-16 | Warning letter Warning letter | Palm Harbor, Florida | — | $99 |
| 2023-06-30 | 483 Form 483 | Palm, Florida | 15 | $99 |
Investigators on these documents
Ivan E. Reyes (1)Samantha J. Pinizzotto (1)Travis S. Bradley (1)
FEI number 3011320041 · most recent document Aug 16, 2024
About Regenerative Processing Plant, LLC
How many FDA Form 483s has Regenerative Processing Plant, LLC received?
FDA Intel has 1 Form 483 on file for Regenerative Processing Plant, LLC; the most recent is dated Jun 30, 2023.
When was Regenerative Processing Plant, LLC last inspected by FDA?
The most recent FDA inspection document on file for Regenerative Processing Plant, LLC is a Form 483 dated Jun 30, 2023, for the site in Palm, Florida.
What did FDA cite at Regenerative Processing Plant, LLC?
The regulations cited most in the observations on file for Regenerative Processing Plant, LLC are 21 CFR 211.42(a) (Design and construction features), 2 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.
Has Regenerative Processing Plant, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Regenerative Processing Plant, LLC; the most recent is dated Aug 16, 2024.